News

| 03 March 2015 |

The Danish Health and Medicines Authority has appointed Anette Lykke Petri as new Head of Division for Supervision as from 1 March 2015. Anette Lykke Petri will be forming the new management team for Public Health Medical Officers East & Supervision, and in cooperation with the management teams of our decentralised divisions in the western parts of Denmark she will implement our action plan for the supervisory function.

| 11 February 2015 |

When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the medicinal product is marketed in Denmark or not (unless the medicinal product is subject to section 11 about omission of the package leaflet, cf. Executive order no. 869 of 21 July 2011, as amended, on the labelling etc. of medicinal products).

| 11 February 2015 |

We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue MIAs in future.

| 10 February 2015 |

| 03 February 2015 |

On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as director was created as part of our action plan aimed at modernising the supervisory function, in which Anne-Marie Vangsted has played a key role since we presented the plan on 15 September 2014.

| 30 January 2015 |

| 30 January 2015 |

We are simplifying the procedure for issuing export certificates for medicinal products.
Previously, an export certificate was sent back and forth between the company and us by ordinary post. We are now simplifying and digitising the process.

| 16 January 2015 |

Marketing authorisation holders of medicinal products authorised under the National Procedure, the Decentralised Procedure, as well as the Mutual Recognition Procedure, should be aware that some ATC codes have been changed in 2015.

| 12 January 2015 |

| 05 January 2015 |

The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors, assessment of applications for the authorisation for clinical investigation of medical devices, and amendments to investigations, as well as supervision and control of notified bodies in Denmark.

| 18 December 2014 |

From 1 January 2015, children will be offered the previous childhood vaccination programme again, because Statens Serum Institut (SSI) can now provide vaccines again after one year with technical production issues.

| 10 December 2014 |

PRAC held its last meeting for this year on 1-4 December 2014. During its December meeting, the PRAC did not initiate or conclude any safety referral. The Committee focused on the broad spectrum of its responsibilities, which cover all aspects of the risk management of the use of medicines.

| 02 December 2014 |

Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow. You can sign up for the newsletter on our website under News. Among the articles in this issue, you can read about how we have developed the pharmacovigilance activities in the recent years.

| 28 November 2014 |

In future, we will comment on medicinal product names applied for (names of human medicines applied for under the mutual recognition (MRP) and decentralised procedures (DCP)) on Day 50 for MRP and on Day 100 for DCP with Denmark as concerned member state, and on Day 70 with Denmark as reference member state.